Utility of [F-18] fluoroDOPA for Neonatal Hyperinsulinism

October 11, 2022 updated by: Lisa States, Children's Hospital of Philadelphia

Localization of Focal Forms of Hyperinsulinism of Infancy With 18F-labeled L-fluoro-DOPA PET Scan

Children with congenital hyperinsulinism (CHI) have low blood sugar, and some of these children may require surgery. In this study, researchers affiliated with the University of Pennsylvania will test how well a radioactive drug (called F-DOPA) can detect a form of hyperinsulinism that may be cured by surgery. Eligible participants in this study will have positron emission tomography (PET) scans with F-DOPA prior to surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

For children with congenital hyperinsulinism (CHI), low blood sugar is caused by cells in the pancreas that release too much insulin. Some children with CHI have these cells throughout their pancreas; others have them located in specific areas of the pancreas. Children who have them located in specific areas of the pancreas may be cured with surgery. F-DOPA is a radioactive drug that may go to these very cells. F-DOPA can also be used for positron emission tomography (or PET), an imaging technique used in nuclear medicine departments. In this study, researchers will test the possibility of using PET with F-DOPA in the diagnosis of children with hyperinsulinism.

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 14 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Any age, but primarily infants 0-6 months.
  • Children with confirmed diagnosis of congenital hyperinsulinism.

Exclusion Criteria:

  • Cases in which surgery will not be considered by parents or guardians.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Subjects who had PET and surgery
Children diagnosed with hyperinsulinism who have failed other non-surgical interventions and are candidates to be scheduled for surgery for partial pancreatectomy. Eligible children will undergo PET imaging with F-DOPA prior to surgery.
Radiation: PET scan
Drug: F-DOPA
0.08-0.16 mCi/kg once
Other Names:
  • 18F-DOPA
  • 18F-labeled L-fluorodeoxyphenylalanine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Accuracy of FDOPA PET to Identify Focal Forms of Hyperinsulinism
Time Frame: up to 1 month post surgical intervention
Comparison of PET scan results with outcome of surgery and histopathology results confirmed as focal or diffuse
up to 1 month post surgical intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of F-DOPA PET
Time Frame: 72 hours maximum or prior to pancreatic surgery
Number of Participants with Adverse Events
72 hours maximum or prior to pancreatic surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Philadelphia

Collaborators

University of Pennsylvania

Investigators

  • Principal Investigator: Lisa J States, MD, Children's Hospital of Philadelphia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

May 5, 2008

First Submitted That Met QC Criteria

May 5, 2008

First Posted (Estimate)

May 7, 2008

Study Record Updates

Last Update Posted (Actual)

November 9, 2022

Last Update Submitted That Met QC Criteria

October 11, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-003683
  • FD-R-003457-01 (Other Grant/Funding Number: FDA orphan drug grant)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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